The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire at day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. Scores range from 0 to 100; higher scores indicate better health status.With a score of 20 or more on the angina-frequency scale indicating that the patient was clinically significant change.

Total score of symptoms questionnaire of TCM [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]

The symptoms questionnaire of TCM consists of 6 symptoms that described in traditional Chinese medicine, including chest pain, chest distress, palpitation, dark-purple lip, dark-purple tongue and unsmooth pulse. Each symptom was assessed by the Visual Analogue Scale（VAS），where a higher score meant higher severity.

The proportion of patients in each treatment group who had clinically significant changes in the other four Seattle Angina Questionnaire scales （The physical limitation, angina stability, treatment satisfaction, and quality of life） [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]

We defined clinical significant changes as a difference of 8 points or more on the physical-limitation scale, 25 or more on the angina-stability scale, 12 or more on the treatment-satisfaction scale, or 16 or more on the quality-of-life scale.

The frequency of anginal attack every week [ Time Frame: Day-7 (if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]

The frequency of anginal attack was recorded by the patients with the use of the diary cards which will be collected from the run-in period (Day -7) to the end of follow-up (Day 90).

Canadian Cardiovascular Society (CCS) grading of angina pectoris [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]

Consumption of Short-acting Nitrates [ Time Frame: Day -7( if exist), Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]

Change in the electrocardiogram (EKG) [ Time Frame: Day 0, Day 7, Day 14, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]

Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]

Incidence of new-onset major vascular events in 90 days [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

Incidence of severe hemorrhages in 90 days [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

The definition of "Severe hemorrhages" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment.

Incidence of moderate hemorrhages in 90 days [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

The definition of "moderate hemorrhages" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise.

Changes in Exercise Tolerance Tests (ETT) at day 14 was defined as change in time to 0.1mv ST-segment depression and change in the Total Exercise Duration (TED) during Exercise Tolerance Testing (ETT) from baseline to day 14.

The profiles of micro-RNA in 60 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ] [ Designated as safety issue: Yes ]

The profiles of mRNA in 60 patients selected from certain centers [ Time Frame: Day 0, Day 14, Day 90 ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ICMJE

Danhong Injection in the Treatment of Chronic Stable Angina

Official Title ICMJE

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina

Brief Summary

The purpose of this study is to evaluate the effect of Danhong Injection on the relief of angina with the use of the Seattle Angina Questionnaire among patients with stable angina patients

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

920

Completion Date

October 2016

Primary Completion Date

October 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Female or male inpatients.

Age: 18 - 70 years.

Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:1）Patients who have a history of myocardial infarction and ST-T changes;2）Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph or CT Angiography; 3）Patients with coronary heart disease were determined by radionuclide angiocardiography.

Patients with moderate angina pectoris (The definition of "moderate angina pectoris " is in accordance with the Canadian Cardiovascular Society (CCS) grading of angina pectoris,which be classified to II or III.

Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

Woman with pregnancy, lactation or positive result of pregnancy test, or woman who is under menstrual period.

Woman who disagree with contraception during treatment period

Patients with severe complications that would make the condition more complicated assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral hemorrhage .

Patients who were angina-free during the run-in period without taking any drug.

Patients with myocardial infarction or Canadian Cardiovascular Society (CCS) grading of angina pectoris class IV within the preceding 3 months